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United States · US · US:0074-7094_392c0320-ca25-423a-9bc1-d06f6badab07

Qulipta

Orange BookUNIISPLATC N02CD07

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAbbVie Inc.
CountryUS (United States)
ATC codeN02CD07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0074709404
    4 TABLET in 1 BOTTLE (0074-7094-04)
  • ndc11
    0074709430
    30 TABLET in 1 BOTTLE (0074-7094-30)
  • ndc11
    0074709470
    4 TABLET in 1 BOTTLE (0074-7094-70)

Annotations

UNII (FDA Substance ID)
7CRV8RR151
ATOGEPANT
RxCUI 2571813
Orange Book
N215206
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7CRV8RR151",
    "rxcui": "2571813",
    "inchikey": "QIVUCLWGARAQIO-OLIXTKCUSA-N",
    "display_name": "ATOGEPANT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8c8ab8f4-32bd-497a-befa-70c8a51d8d52": {
      "match": "brand_token",
      "title": "QULIPTA (ATOGEPANT) TABLET [ABBVIE INC.]",
      "spl_version": "19",
      "published_date": "2026-02-10"
    }
  },
  "productid": "0074-7094_392c0320-ca25-423a-9bc1-d06f6badab07",
  "productndc": "0074-7094",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "215206",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Sep 28, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Sep 28, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "60MG",
        "product_no": "003",
        "approval_date": "Sep 28, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATOGEPANT",
  "proprietary_name": "Qulipta",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA215206",
  "marketing_category": "NDA",
  "nonproprietary_name": "Atogepant",
  "start_marketing_date": "20210930",
  "active_numerator_strength": "60"
}

Related drugs

Other records sharing ATC code N02CD07.

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